NCT06026358

Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands

Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands. An Internally Placebo Controlled, Partly Blinded Clinical Pilot Study

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Interventional, monocentric, national, internal placebo-controlled, prospective pilot study, consisting of two parts, A (single-blinded) and B (open) to assess Efficacy of Tirbanibulin for the treatment of AK on the back of the hand. In part A, eligible subjects receive Tirbanibulin on the left hand and placebo on the right hand for 5 d in a single-blinded manner. Safety and efficacy are assessed at day 8 (± 1 d) (3 days after the end of treatment (EoT+3) and day 57 (± 7 d) after the start of the treatment. Pictures will be taken at baseline, 8 d and 57 d (± 7 d) as per protocol and optional during unscheduled visits.

Conditions

• Actinic Keratoses

Interventions

Type	Name	Description
DRUG	Tirbanibulin	subjects receive 2,5 mgTirbanibulin in 250 mg ointment with daily administration of one single sachet on the left hand and 250mg ointment placebo on the right hand for 5 d in a single-blinded manner.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-09-07
• Last updated: 2024-05-30